SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth structure, c
Summary
The FDA issued a Class II for SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious ma by Coltene Whaledent Inc. Reason: Screw connection between the turbine head and the push button may loosen and fall off during the treatment, and increase the risk of swallowing or inh.
Details
Source
Device Recall
External ID
Z-1208-2023
Action Date
2023-03-08
Status
Ongoing
Category
device
Product Description
SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations and for polishing teeth. Model Number: S10001
Lot/Code Info: UDI-DI: +ESANS100010 All Serial Numbers
Quantity Affected: 3896 units
Reason for Recall
Screw connection between the turbine head and the push button may loosen and fall off during the treatment, and increase the risk of swallowing or inhaling part of the turbines head or the push button
Distribution
Nationwide Foreign: Canada Germany Indonesia Ireland Lebanon Saudia Arabia Turkey
Type: Voluntary: Firm initiated
Recall Initiated: 2023-01-20
Company
Cuyahoga Falls, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 149 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Coltene Whaledent Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Coltene Whaledent Inc have FDA actions?
This is the only FDA action we have on record for Coltene Whaledent Inc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1208-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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